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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER

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EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER Back to Search Results
Catalog Number 320-46-03
Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Disorder (2373); No Information (3190)
Event Date 01/30/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision of shoulder components due to loosening.
 
Manufacturer Narrative
Pending evaluation.Updated with device information and index surgery date.Mdr is associated with 1038671-2018-00270.
 
Event Description
Revision of shoulder components due to loosening.
 
Event Description
The revision surgery was related to a post traumatic event, the patient was lifting a 50 lb bag of mulch.Associated mfrs for this event: 1038671-2018-00270.
 
Manufacturer Narrative
It is noted in the ifu that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.There is no indication that there is a device related problem/malfunction.The most likely cause of the reported event is related to patient weight and strenuous activity.Correction, no device evaluation to be performed.This device is used for treatment, not diagnosis.
 
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Brand Name
EQUINOXE REVERSE HUMERAL LINER
Type of Device
EQUINOXE REVERSE HUMERAL LINER
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7296047
MDR Text Key100915808
Report Number1038671-2018-00211
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K063569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date05/03/2020
Device Catalogue Number320-46-03
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/20/2018
Initial Date FDA Received02/26/2018
Supplement Dates Manufacturer Received02/20/2018
11/30/2018
Supplement Dates FDA Received04/01/2018
11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight156
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